Final answer:
Pharmacies are required to keep a patient profile for each individual receiving prescription drugs, following FDA regulations ensuring safety and efficacy. The FDA's strict drug approval process protects patients from unsafe medications, but can also delay access to new treatments, affecting patients and pharmaceutical companies.
Step-by-step explanation:
Pharmacies are indeed required to maintain a patient profile or medication record for each patient that receives a prescription drug or device. This ensures the ongoing safety and efficacy of medications dispensed to the public. The Food and Drug Administration (FDA) plays a significant role in the regulation of medicines, requiring rigorous testing before drugs can be marketed to ensure they are safe for consumption.
However, the strict regulations imposed by the FDA have both winners and losers in the system. The 'winners' are the public who are safeguarded from the potential dangers of untested and unsafe drugs. On the other hand, the 'losers' may include the patients who could potentially benefit from innovative treatments that are delayed due to the lengthy approval process, and companies that have to bear the extensive costs of this process.
The importance of pharmacovigilance systems cannot be overstated, as they enable the continuous monitoring of drugs post-approval. This helps to assess the drug's long-term safety and its effects on specific patient subgroups, ensuring that the risk to individual privacy is balanced against the benefits of treatment.